BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORDE BUL LOR 9X8X27, 5 DG

    MDR report key: 7133002 · Received December 20, 2017

    Report

    Report Number
    1526439-2017-50099
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    November 29, 2017
    Report Date
    November 29, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    UDI-DI
    10705034140056
    PMA / PMN Number
    K041722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ONE CONCORDE BULLET LORDOTIC 9X8X27 5 DEGREE CAGE WAS RECEIVED BY THE CUSTOMER QUALITY UNIT FOR EVALUATION. VISUAL EXAMINATION FOUND THAT THE CAGE HAD FRACTURED INTO MULTIPLE PIECES. A REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. A DEFINITIVE ROOT CAUSE FOR THE CONCORDE CAGE FRACTURING CANNOT BE POSITIVELY DETERMINED. HOWEVER, IT SHOULD BE NOTED THAT POLYMER/CARBON-FIBER CAGES ARE DESIGNED TO SUPPORT PHYSIOLOGIC LOADS. HIGHER THAN ANTICIPATED TORQUE LEVELS WHEN APPLIED TO INSERTION TOOLS, CAN CAUSE SPLITTING OR FRACTURE OF CAGES. NO ISSUES WERE IDENTIFIED IN THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THEREFORE, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO IMPLANT A CONCORDE BULLET INTERBODY FUSION CAGE, THE CAGE BROKE INTO SEVERAL PIECES. THE PIECES WERE RETRIEVED AND WILL BE SENT BACK TO THE HEAD OFFICE PATIENT CONSEQUENCE? :NO. ACTION TAKEN FOR PROCEDURE:COMPLETED WITH ANOTHER CONCORDE BULLET INTERBODY FUSION CAGE. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913326 CONCORDE BUL LOR 9X8X27, 5 DG SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE 10705034140056

    Patients

    Seq Age Sex Outcome Treatment
    1